FDA 510(k) Applications for Medical Device Product Code "KGI"
(Densitometer, Bone)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220822 | 3D-Shaper Medical S.L | 3D-SHAPER | 12/09/2022 |
| K000162 | ALARA, INC. | METRISCAN BONE DENSITY SYSTEM | 05/12/2000 |
| K984285 | COMPUMED, INC. | OSTEOGRAM BONE DENSITOMETER | 05/19/1999 |
| K091325 | COOPER SURGICAL | TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS | 06/29/2009 |
| K033550 | DEMETECH AB | DXL CALSCAN | 05/05/2004 |
| K011917 | GE LUNAR CORP. | ADVANCED HIP ASSESSMENT SOFTWARE | 08/03/2001 |
| K030962 | GE LUNAR CORP. | DPX SERIES BRAVO DUO BONE DENSITOMETER | 07/25/2003 |
| K023554 | GE LUNAR CORP. | DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE | 12/20/2002 |
| K113286 | GE MEDICAL SYSTEMS LUNAR | ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS | 04/27/2012 |
| K071570 | GE MEDICAL SYSTEMS LUNAR | GE LUNAR BODY COMPOSITION SOFTWARE | 06/27/2007 |
| K133664 | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGN | ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS | 05/15/2014 |
| K191112 | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | GEHC DXA Bone Densitometers with enCORE version 18 | 09/19/2019 |
| K180782 | GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC | Aria | 04/20/2018 |
| K161682 | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC | GE Lunar DXA Bone Densitometers with enCORE version 17 | 12/02/2016 |
| K072439 | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | 09/14/2007 |
| K072664 | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA | GE LUNAR FEMUR STRENGTH SOFTWARE | 11/21/2008 |
| K103730 | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA | GE LUNAR VISCERAL FAT SOFTWARE | 05/06/2011 |
| K052581 | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA | LUNAR IDXA | 10/20/2005 |
| K082317 | GENERAL ELECTRIC CO. | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | 09/26/2008 |
| K213760 | HeartLung Corporation | ABMD Software | 07/29/2022 |
| K080711 | HOLOGIC, INC. | 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION | 09/02/2008 |
| K072847 | HOLOGIC, INC. | APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS | 03/28/2008 |
| K961787 | HOLOGIC, INC. | BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS | 06/13/1997 |
| K992677 | HOLOGIC, INC. | EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W | 09/03/1999 |
| K983028 | HOLOGIC, INC. | FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W | 11/13/1998 |
| K061561 | HOLOGIC, INC. | HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS | 07/28/2006 |
| K033224 | HOLOGIC, INC. | HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER | 11/05/2003 |
| K963363 | HOLOGIC, INC. | HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS | 11/22/1996 |
| K023398 | HOLOGIC, INC. | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY | 11/08/2002 |
| K002711 | HOLOGIC, INC. | HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER | 09/28/2000 |
| K113356 | HOLOGIC, INC. | HOLOGIC VISCERAL FAT SOFTWARE | 03/06/2012 |
| K042480 | HOLOGIC, INC. | INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS | 10/29/2004 |
| K060111 | HOLOGIC, INC. | IVA (MXA II SOFTWARE OPTION) | 04/24/2006 |
| K103265 | HOLOGIC, INC. | NHANES WHOLE BODY DXA REFERENCE DATABASE | 03/16/2011 |
| K992775 | HOLOGIC, INC. | OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W | 10/01/1999 |
| K041266 | HOLOGIC, INC. | PEDIATRIC REFERENCE DATABASE | 08/11/2004 |
| K130277 | HOLOGIC, INC. | SINGLE ENERGY (SE) FEMUR EXAMS | 05/31/2013 |
| K031991 | IMAGE ANALYSIS, INC. | DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS | 07/30/2003 |
| K992246 | IMAGE ANALYSIS, INC. | QCT BONE MINERAL ANALYSIS SOFTWARE | 09/03/1999 |
| K082402 | IMAGING THERAPEUTICS, INC. | OSDX HIP BMD SYSTEM | 10/16/2008 |
| K113616 | LONE OAK MEDICAL TECHNOLOGIES, LLC | ACCUDXA2 | 04/27/2012 |
| K982267 | LUNAR CORP. | DPX-RX BONE DENSITOMETER | 08/18/1998 |
| K964307 | LUNAR CORP. | EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS | 04/16/1997 |
| K961007 | LUNAR CORP. | EXPERT SPINE MORPHOTIETRY REFERENCE | 07/25/1996 |
| K964263 | LUNAR CORP. | EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE | 11/07/1996 |
| K974437 | LUNAR CORP. | EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE | 02/13/1998 |
| K972517 | LUNAR CORP. | EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE | 11/18/1997 |
| K983271 | LUNAR CORP. | FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS | 11/18/1998 |
| K983269 | LUNAR CORP. | FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER | 11/18/1998 |
| K983262 | LUNAR CORP. | FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS | 11/18/1998 |
| K961944 | LUNAR CORP. | LUNAR REPORT GENERATOR | 07/03/1996 |
| K001756 | LUNAR CORP. | LUNAR REPORT GENERATOR II | 07/06/2000 |
| K983724 | LUNAR CORP. | ORCA-DX BONE DENSITOMETER | 12/08/1998 |
| K001812 | LUNAR CORP. | PEDIATRIC REFERENCE DATA | 07/10/2000 |
| K970224 | LUNAR CORP. | PIXI BONE DENSITOMETER | 04/16/1997 |
| K972053 | LUNAR CORP. | PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM | 08/08/1997 |
| K000826 | LUNAR CORP. | PRODIGY LATERAL VIEW SOFTWARE | 04/14/2000 |
| K983564 | LUNAR CORP. | PRODIGY TOTAL BODY SOFTWARE | 12/08/1998 |
| K983273 | MEDICAL SYSTEMS, INC. | XCT 2000 L PQCT BONE DENSITOMETER | 10/29/1998 |
| K121716 | MEDIMAPS GROUP SA | TBS INSIGHT | 10/05/2012 |
| K152299 | MEDIMAPS GROUP SA | TBS iNsight | 04/29/2016 |
| K030330 | MINDWAYS SOFTWARE, INC. | CTXA HIP EXTENDED REFERENCE DATA | 06/20/2003 |
| K002113 | MINDWAYS SOFTWARE, INC. | CTXA HIP; CTXA; QCT PRO CTXA HIP | 12/04/2001 |
| K140342 | MINDWAYS SOFTWARE, INC. | QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT | 08/29/2014 |
| K972882 | NORLAND CORP. | APOLLO | 10/31/1997 |
| K980569 | NORLAND CORP. | FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS | 06/12/1998 |
| K980289 | NORLAND CORP. | FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER | 06/12/1998 |
| K973459 | NORLAND CORP. | NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS | 02/13/1998 |
| K973104 | NORLAND CORP. | NORLAND MODEL PDEXA BONE DENSITOMETER | 01/29/1998 |
| K980125 | NORLAND CORP. | REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER | 05/20/1998 |
| K993337 | NORLAND MEDICAL SYSTEMS, INC. | APOLLO MULTI-RACIAL REFERENCE POPULATION | 05/16/2000 |
| K993176 | NORLAND MEDICAL SYSTEMS, INC. | MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY | 06/20/2000 |
| K992125 | NORLAND MEDICAL SYSTEMS, INC. | XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 | 11/22/1999 |
| K113725 | O.N. DIAGNOSTICS | VIRTUOST | 09/13/2012 |
| K220402 | O.N. Diagnostics | VirtuOst | 05/19/2023 |
| K963789 | OSTEOMETER MEDITECH A/S | DTX-100 BONE DENSITOMETER | 07/14/1997 |
| K964562 | OSTEOMETER MEDITECH A/S | DTX-200 BONE DENSITOMETER | 08/22/1997 |
| K021331 | OSTEOMETER MEDITECH, INC. | DEXACARE G4 | 05/21/2002 |
| K003656 | PRONOSCO A/S | X-POSURE SYSTEM VERSION 2 MAMMO | 12/15/2000 |
| K002500 | PRONOSCO A/S | X-POSURE SYSTEM VERSION 2 RAD | 10/23/2000 |
| K971735 | SCHICK TECHNOLOGIES, INC. | ACCUDEXA BONE DENSITOMETER | 12/02/1997 |
| K981124 | SCHICK TECHNOLOGIES, INC. | ACCUDEXA BONE DENSITOMETER | 06/04/1998 |
| K001429 | SCHICK TECHNOLOGIES, INC. | MODIFICATION TO ACCUDEXA BONE DENSITOMETER | 05/26/2000 |
| K021527 | SECTRA-IMTEC AB | SECTRA OSTEOPOROSIS PACKAGE | 06/07/2002 |
| K961011 | SHOTWELL & CARR, INC. | DTX-200 BONE DENSITOMETER | 07/05/1996 |
| K984178 | TORSANA OSTEOPOROSIS DIAGNOSTICS A/S | PRONOSCO X-POSURE SYSTEM | 02/18/1999 |
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